Kohler 1980.
| Study characteristics | |||
| Patient sampling |
Country USA Study design Retrospective casenote review. Setting Hospital Dates of data collection 1971 ‐ 1974 Population (n) 144 Inclusion criteria Surgically confirmed adenocarcinoma of colon or rectum Exclusion criteria N/R Participants Included (n) 49 |
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| Patient characteristics and setting |
Age range N/R Smoking status N/R Site of primary tumour Colorectal Stage of primary tumour N/R Perioperative investigations done to ensure no residual disease N/R Chemotherapy/radiotherapy? N/R Recurrences (n) 22 Site of recurrences N/R |
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| Index tests |
CEA timing Not clear CEA technique Hansens radioimmunoassay CEA threshold 2.5 µg/L Definition of positive 1 elevated value Which CEA value (s) used? All |
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| Target condition and reference standard(s) |
Follow‐up schedule N/R |
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| Flow and timing |
Timing of CEA vs reference standard (days) N/R |
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| Comparative | |||
| Notes | |||
| Methodological quality | |||
| Item | Authors' judgement | Risk of bias | Applicability concerns |
| DOMAIN 1: Patient Selection | |||
| Was a consecutive or random sample of patients enrolled? | Unclear | ||
| Did the study avoid inappropriate exclusions? | Unclear | ||
| Unclear | Low | ||
| DOMAIN 2: Index Test All CEA thresholds | |||
| If a threshold was used, was it pre‐specified? | Unclear | ||
| Is the same method and instrument used for all CEA measurements? | Yes | ||
| Is there an estimation of reproducibility of the method, for example the % coefficient of variation at specific concentrations? | No | ||
| Is there an indication of method accuracy, for example, is there evidence of participation in an external quality assessment and proficiency testing scheme? | No | ||
| Low | Low | ||
| DOMAIN 3: Reference Standard | |||
| Is the reference standards likely to correctly classify the target condition? | Unclear | ||
| Were the reference standard results interpreted without knowledge of the results of the index tests? | No | ||
| Unclear | Unclear | ||
| DOMAIN 4: Flow and Timing | |||
| Did all patients receive the same reference standard? | Unclear | ||
| Were all patients included in the analysis? | No | ||
| Was the index test repeated prior to the reference standard? | Unclear | ||
| Was the the timing between index test(s) and reference standard ascertainable? | No | ||
| Did all patients receive a reference standard? | Unclear | ||
| High | |||